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Monitoring of host cell proteins (HCPs) during the manufacture of monoclonal antibodies (mAb) has become a critical requirement to provide effective and safe drug product. ELISA assays are still the current gold standard for the quantification of protein impurities. However, this technique has sever...
ORGANISM(S): Cricetulus griseus (Chinese hamster) (Cricetulus barabensis griseus) 
2023-07-20 | PXD029305 | Pride
This dataset contains raw and processed LC–MS/MS data generated for a prospective validation of label-free untargeted proteomics for host cell protein (HCP) quantification in biotherapeutic matrices. A stable isotope-labeled CHO whole-proteome standard was spiked into the NIST monoclonal antibody re...
ORGANISM(S): Mus musculus (Mouse) 
2026-06-08 | PXD075694 | Pride
In this study, we developed powerful and reproducible MS-based analytical workflows coupling optimized and efficient sample preparations, library-free DIA acquisition method and stringent validation criteria. The performances of several preparation protocols and DIA versus classical DDA were evaluat...
ORGANISM(S): Cricetulus griseus (Chinese hamster) (Cricetulus barabensis griseus) 
2020-10-19 | PXD019668 | Pride
In this study, we investigated the benefits of adding high-field asymmetric ion mobility spectrometry (FAIMS) separation prior to data dependent acquisition (DDA) and gas phase fractionation (GPF) prior to data independent acquisition (DIA) LC-MS/MS analysis. Native digestion followed by LC-MS/MS wi...
ORGANISM(S): Mus musculus (Mouse) Cricetulus griseus (Chinese hamster) (Cricetulus barabensis griseus) 
2023-05-07 | PXD039582 | Pride
In this study, we investigated the benefits of adding high-field asymmetric ion mobility spectrometry (FAIMS) separation prior to data dependent acquisition (DDA) and gas phase fractionation (GPF) prior to data independent acquisition (DIA) LC-MS/MS analysis. Native digestion followed by LC-MS/MS wi...
ORGANISM(S): Mus musculus (Mouse) Cricetulus griseus (Chinese hamster) (Cricetulus barabensis griseus) 
2023-05-07 | PXD039585 | Pride
There is a growing industry and regulatory need to detect host cell protein (HCP) impurities in the production of protein biopharmaceuticals, as certain HCPs can impact product stability, safety, and efficacy, even at low levels.1-6 In some cases, regulatory agencies require the identification as we...
ORGANISM(S): Mus musculus (Mouse) 
2020-06-02 | PXD018427 | Pride
Host cell protein (HCP) impurities are considered a critical quality attribute of biopharmaceuticals because of their potential to compromise safety and efficacy, and LC/MS-based analytical methods have been developed to identify and quantify individual proteins instead of employing enzyme-linked im...
ORGANISM(S): Cricetulus Griseus 
Host cell proteins (HCPs) are critical quality attributes in biotherapeutics that require accurate, specific, and comprehensive quantification. Mass spectrometry (MS)-based workflows are increasingly adopted to overcome the coverage and specificity limitations of immunoassays. This study benchmarks ...
ORGANISM(S): Cricetulus Griseus (ncbitaxon:10029) 
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